A Bioequivalence Study of Advil Tablet (Mini) (Ibuprofen 200 mg) Versus Advil Tablet (Ibuprofen 200 mg) in Healthy Adult Subjects Under Fasted Conditions and Bioavailability Assessment of Advil Tablet (Mini) Under Fed Conditions
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · None · Other
Enrollment
50actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-12-17 | actual | When the study began enrolling |
| Primary completion | 2026-02-03 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-02-03 | actual | The whole study's end, after follow-up |
| First posted | 2026-01-15 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Bioequivalence
- Bioavailability
Interventions
- Drug: Advil Tablet (Mini) (Test Product)
- Drug: Advil Tablet (Reference Product)
Primary outcomes
what the primary-completion date above is the date OFMaximum Observed Post-dose Concentration (Cmax) Under Fasted Conditions (Test Versus (vs) Reference Product)
measured Pre-dose (within 1 hour prior to dosing) and at 5,10,15,30,45 minutes and 1,1.25,1.5,1.75,2,2.25,2.5,2.75,3,3.25,3.5,3.75,4,4.25,4.5,4.75,5,5.5,6,8,10,12,16 and 24 hours post-dose on Day 1 in each treatment period (each treatment period is 3 days)
Area Under the Plasma Concentration Versus Time Curve Calculated from Time 0 to the Last Measurable Sampling Time Point, t (AUC[0-t]) Under Fasted Conditions (Test Vs Reference Product)
measured Pre-dose (within 1 hour prior to dosing) and at 5,10,15,30,45 minutes and 1,1.25,1.5,1.75,2,2.25,2.5,2.75,3,3.25,3.5,3.75,4,4.25,4.5,4.75,5,5.5,6,8,10,12,16 and 24 hours post-dose on Day 1 in each treatment period (each treatment period is 3 days)
Cmax for Test Product Under Fed Conditions Compared to Fasted Conditions
measured Pre-dose (within 1 hour prior to dosing) and at 5,10,15,30,45 minutes and 1,1.25,1.5,1.75,2,2.25,2.5,2.75,3,3.25,3.5,3.75,4,4.25,4.5,4.75,5,5.5,6,8,10,12,16 and 24 hours post-dose on Day 1 in each treatment period (each treatment period is 3 days)
AUC(0-t) for Test Product Under Fed Conditions Compared to Fasted Conditions
measured Pre-dose (within 1 hour prior to dosing) and at 5,10,15,30,45 minutes and 1,1.25,1.5,1.75,2,2.25,2.5,2.75,3,3.25,3.5,3.75,4,4.25,4.5,4.75,5,5.5,6,8,10,12,16 and 24 hours post-dose on Day 1 in each treatment period (each treatment period is 3 days)
Area Under the Plasma Concentration Versus Time Curve Calculated From Time 0 to Infinity (AUC[0-inf]) for Test Product Under Fed Conditions Compared to Fasted Conditions
measured Pre-dose (within 1 hour prior to dosing) and at 5,10,15,30,45 minutes and 1,1.25,1.5,1.75,2,2.25,2.5,2.75,3,3.25,3.5,3.75,4,4.25,4.5,4.75,5,5.5,6,8,10,12,16 and 24 hours post-dose on Day 1 in each treatment period (each treatment period is 3 days)
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